EDITORS' DESK

  • The “Isle Of Difference” In Contract Development And Manufacturing
    The “Isle Of Difference” In Contract Development And Manufacturing

    On the way to Life Science Leader magazine’s annual CMO Leadership Awards in Manhattan, we detoured to the “Isle of Difference.” This is a location where service providers devise sales and marketing strategies to entice circling customers to put down anchors with them, instead of at a competitor’s shores. 

At Novartis, It’s The Quality In Continuous Manufacturing

The head of continuous manufacturing at Novartis has a different view from the director of the Novartis-MIT Center for Continuous Manufacturing, when it comes to the technology's top benefit. “For the first time in history,” says Markus Krumme, “the industry can operate such that there's a 100% quality verification.”

Outsourced Pharmaceutical Manufacturing Grows To $76 Billion

The outsourced manufacturing sector should continue its growth at a clip of 6.6% over the next five years, faster than the projected annual growth rate of the overall pharmaceutical industry (5.5%). That’s according to a new report from Results Healthcare, Pharma & Biotech 2017 Review of outsourced manufacturing.

Novartis And The Arrival Of The Continuous Manufacturing Facility

The journey to implementation of the disruptive technology of continuous manufacturing began in 2005, according to Markus Krumme of Novartis, with a single question on a slide presented to Novartis development and manufacturing executives. “Why don’t we have facilities that can continuously produce materials?” then-CEO Daniel Vasella asked.

Three Experiences Power A Non-Profit’s Business Approach

Jennifer Dent is all business. At a nonprofit organization. She thinks that's exactly how it’s supposed to be. She also shares the enthusiasm of a humanitarian on a mission. Reviewing three experiences in the career of Dent, president of BIO Ventures for Global Health (BVGH), one might think none of this should be the case.

More From Chief Editor Louis Garguilo

GUEST CONTRIBUTORS

  • 5 Key Takeaways From The FDA's Revised Quality Metrics Guidance
    5 Key Takeaways From The FDA's Revised Quality Metrics Guidance

    On November 23, 2016, FDA published Submission of Quality Metrics Data, a draft guidance that addresses industry comments on an earlier draft guidance titled Request for Quality Metrics (2015). This article discusses the most significant differences between the two documents  and what pharmaceutical manufacturers and CMOs should take away from these changes.

  • 5 Key Components Of A Compliant Disinfectant Efficacy Testing Package (Part 1)
    5 Key Components Of A Compliant Disinfectant Efficacy Testing Package (Part 1)

    Microbial contamination control is essential in ensuring consumer safety, especially in controlled environments. Disinfectants play an important role in controlling microbial contamination on surfaces. The term disinfectant is often broadly used to describe chemical agents used to reduce the microbial load of controlled environments.

  • Overcoming The Manufacturing Hurdles Of Cell & Gene Therapy
    Overcoming The Manufacturing Hurdles Of Cell & Gene Therapy

    A number of innovative cellular and gene therapies are in development, and R&D and investments in these fields are rapidly growing. Although the number of approvals and markets remain very small — negligible by the standards of the mainstream (bio)pharmaceutical industry — this is likely to change as the first clinical trials are successfully concluded.

  • How Many Team Members Does It Take To Determine The Study Status?
    How Many Team Members Does It Take To Determine The Study Status?

    Sitting on one of those long, painful, study status update calls recently, I was reminded of the famous light bulb joke. You know the one: “How many engineers (lawyers, politicians, etc.) does it take to change a light bulb?”  I was both flabbergasted and frustrated that, after 45 minutes, the project manager was still wading through status updates from a myriad of CRO and vendor partners and CRAs — just to figure out where the study was from a site activation and enrollment standpoint.  

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PHARMA OUTSOURCING WHITE PAPERS

More Pharma Outsourcing White Papers

ABOUT US

Welcome to OutsourcedPharma.com, the website dedicated to pharmaceutical drug development services.

Outsourced Pharma provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and health care markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their Bio and Pharma sponsors. Outsourced Pharma is part of the Life Science Connect media group, and also a sponsor of Outsourced Pharma West conferences.

With regular sections on pharmaceutical drug development, contract manufacturing, contract research services, contract packaging services, formulation & development services, contract analytical testing, API (Active Pharmaceutical Ingredients) manufacturing, stability testing services  and other areas in pharmaceutical contract development and manufacturing, we bring complete coverage of outsourcing trends and issues to the pharmaceutical contract development and manufacturing marketplace.

Use our supplier directory and offline search service to expedite your discovery of CMOs, CDMOs, CROs, and functional service providers. Please take a moment to join our community and discover the benefits of your free membership.

The vision of Life Science Leader and Life Science Connect is to help facilitate connections and foster collaborations in pharmaceutical and medical device development to find ways to get more life-saving and life-improving therapies to market. Connect, Collaborate, Contribute.

Louis Garguilo Articles

INDUSTRY INSIGHTS

  • What Makes A Successful Due Diligence When In-Licensing A Pharmaceutical Product?
    What Makes A Successful Due Diligence When In-Licensing A Pharmaceutical Product?

    When a company is looking at acquiring or in-licensing a pharmaceutical product, there are a few technical factors that should be carefully considered before the deal is completed. 

  • Packed Session Illustrates Reason For Excitement Around Advanced Cancer Therapies
    Packed Session Illustrates Reason For Excitement Around Advanced Cancer Therapies

    There are many reasons to be excited by the science being presented at this year’s American Society for Clinical Oncology meeting. The data presented at a special section on Saturday morning opened the door to a future when tumor genetics and biomarkers will change the way we think of about cancer treatment. As a physician working in clinical development, there is also the excitement around intriguing new questions that when answered could lead to life-saving treatments unimaginable just a decade ago. 

    More than 2,000 people packed into a cavernous conference hall at 8 a.m. on Saturday – demonstrating the high level of shared interest in emerging immunotherapies.  

  • Shift From Central Lab To POC
    Shift From Central Lab To POC

    As new technologies work to change the market space, this article takes a look at the market forces that are helping and hindering the shift to zero wait time for patient test results. Comprehensive analysis of both test settings allows for better understanding of the diagnostic landscape as it exists today, offering insight to both product and process innovations for your next generation product.

  • The Direct-To-Patient Model: Your Top 10 Q&A

    In clinical trials, a direct-to-patient model allows for drug therapies to be delivered and administered in the patient’s home and/or biological samples to be taken and uplifted from the patient’s home. Depending on the complexity of the trial protocols, patients may take medicines themselves, or rely on a homecare nurse or caregiver for clinical support. Because the direct-to-patient model allows the patient to participate in the clinical trial from home, it reduces the need for them to travel to the investigator site, increasing the likelihood they will agree to participate and decreasing the possibility that they will drop out of the study.

  • NEW DOCUMENT

    Manufacturing of biopharmaceuticals is a large commitment to the public health and helps save the lives of millions of people. The complex nature of biopharmaceuticals makes manufacturing a challenge, in which a consistent, high-quality end product is dependent of the use of equally consistent, high-quality key manufacturing components.

     

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OUTSOURCING EVENTS

The New Medical Device Reporting (MDR) Guidance – An Easily Digestible Compliance Breakdown February 27, 2017
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
CRO Oversight: Risk Assessment & Action Planning March 1, 2017
1pm-2:30pm EST, Online Training
Price:  $299 - Includes Bonus Handouts!
Understanding The New NIH/HHS Final Rule On Clinical Trial Reporting – Tips For Compliance Success March 2, 2017
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Adverse Event Reporting: Avoiding Common Pitfalls March 7, 2017
1pm-2:30pm EST, Online Training
Price:  $299 - Includes Bonus Handouts!
Bioprocess Facility Design - Layout Rules and Configurations March 8, 2017
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
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